Advisor – Commissioning & Qualification

Eli Lilly and Company

. Serve as C&Q technical authority for assigned major and mega facilities across the full project lifecycle .

Posted 11/10/2026full-timeUnited StatesSeniorLead💰 $130,500 - $211,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Commissioning and Qualification (C&Q) processes within the pharmaceutical industry, including lifecycle oversight, regulatory compliance, and project management. Proven ability to lead large-scale C&Q programs, mentor teams, and drive continuous improvement initiatives.

Highest-signal resume keywords

Commissioning & Qualification ExperienceGMP KnowledgeProject Management SkillsASTM E2500 Verification ApproachElectronic C&Q Documentation Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

C&Q MethodologyTest Case DevelopmentOperational VerificationRisk-Based VerificationProgram ManagementContinuous ImprovementBudget OversightSchedule ManagementField CommissioningSystem Turnover

Soft Skills

MentoringCoachingCommunication SkillsInterpersonal SkillsStakeholder Alignment

Tools & Technologies

Kneat™Electronic Documentation Systems

Industry Keywords

Pharmaceutical Capital ProjectsProcess SafetyRegulatory ComplianceGMP StandardsBrownfield FacilityGreenfield Facility

About the role

Key responsibilities & impact

Serve as C&Q technical authority for assigned major and mega facilities across the full project lifecycle
Provide lifecycle oversight from conceptual/basic design through construction, FAT/SAT, field commissioning and verification, system turnover and closeout
Ensure technical understanding of GMP- and process-safety-regulated systems, utilities and process equipment
Define C&Q strategy and execution plans for assigned projects
Champion Lilly’s C&Q methodology and execution across the portfolio
Oversee portfolio-level C&Q strategy and alignment with business processes, industry standards and regulatory expectations
Drive standardization and reuse of C&Q approaches, templates, tools and lessons learned
Define, track and report C&Q metrics and drive continuous improvement
Coach and mentor project C&Q Leads and teams
Train project teams and service providers on the Lilly C&Q program
Lead escalation and resolution of technical, compliance, field-execution and cross-discipline issues
Represent C&Q at project leadership forums and surface risks and issues
Oversee C&Q scope, schedule and budget across assigned projects
Support test-case development and field-execution planning and logistics
Apply disciplined program management in compliance with company policies and procedures
Uphold Safety First and Quality Always practices, including C&Q safety, permitting and method-statement requirements
Collaborate with project management, design, engineering, automation, construction, QA and business partners
Improve GFD C&Q processes, procedures and training

Requirements

What you’ll need

Bachelor of Science in Engineering, related science, Project Management or a related field
Minimum of 15 years of Commissioning & Qualification experience within major or mega pharmaceutical capital project delivery
Direct experience executing C&Q test cases and methodologies, including receipt, installation and operational verification
Experience as a C&Q Manager/Lead across the full lifecycle of at least one brownfield or greenfield pharmaceutical facility
Working knowledge of GMP, process safety and regulatory requirements for commissioning and qualification
Working knowledge of the ASTM E2500 Verification approach
Experience with electronic C&Q documentation systems such as Kneat™
Understanding of how electronic C&Q documentation tools interact with the C&Q process
Authorized to work in the United States on a full-time basis
Proven track record leading and providing oversight to large-scale C&Q programs concurrently
Demonstrated ability to mentor, coach and develop C&Q Leads and project teams
Strong project-management capability across scope, schedule, budget and risk on major and mega capital programs
Ability to frame complex decisions, facilitate resolution and align stakeholders across sites, corporate engineering, A/E firms and contract partners
Strong knowledge of the ASTM E2500 Model and risk-based verification methodology
Familiarity with industry standards and regulatory expectations for C&Q
Excellent written and verbal communication skills with technical and non-technical audiences
Strong interpersonal skills within multi-discipline teams
Willingness to embrace continuous improvement and act as an agent for change

Benefits

Comp & perks

Company bonus depending on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
Disability accommodation support during the application process